FDA.reportPublic FDA data

OrangeCAD Med

Primary DI
04262365192943
Brand
OrangeCAD Med
Company
OrangeCAD MED GmbH
Model
31.023.71.031H
Catalog number
31.023.71.031H
Device description
Driver for ratchet
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262365192943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262365192943042623651929434262365192943

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
343793874
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262365191120OrangeCAD MedSMBL2707HSMBL2707H2026-01-09
04262365191502OrangeCAD MedSMBL2706HSMBL2706H2026-01-09
04262365191540OrangeCAD MedSMBL2705HSMBL2705H2026-01-09
04262365191557OrangeCAD MedSMBL2704HSMBL2704H2026-01-09
04262365191564OrangeCAD MedSMBL2703HSMBL2703H2026-01-09
04262365191571OrangeCAD MedSMBL2708HSMBL2708H2026-01-09
04262365192790OrangeCAD MedSMBL5010HSMBL5010H2026-01-09
04262365193537OrangeCAD Med31.025.23.031H31.025.23.031H2026-01-09
04262365193551OrangeCAD Med31.022.71.025H31.022.71.025H2026-01-09
04262365193575OrangeCAD Med31.024.23.025H31.024.23.025H2026-01-09
04262365194084OrangeCAD MedSMBL5201HSMBL5201H2026-01-09
04262365195104OrangeCAD Med31.030.00.188H31.030.00.188H2026-01-09
04262365195210OrangeCAD Med31.064.71.031H31.064.71.031H2026-01-09
04262365195364OrangeCAD MedSMBL5301HSMBL5301H2026-01-09
04262365195470OrangeCAD MedSMBL5701HSMBL5701H2026-01-09
04262365195593OrangeCAD MedSMBL5601HSMBL5601H2026-01-09
04262365195746OrangeCAD MedSMBL5003HSMBL5003H2026-01-09
04262365195906OrangeCAD MedIPS-14-41IPS-14-412026-01-09
04262365195913OrangeCAD MedSMBL5401HSMBL5401H2026-01-09
04262365195920OrangeCAD Med31.063.71.025H31.063.71.025H2026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09